Small-molecule API: Regulation compliant, reliable particle sizing using the Mastersizer 3000+
Instrument adaptability and reliability, together with regulatory compliance and ease of method transfer.
The Mastersizer range has long been well-regarded by the pharmaceutical industry for its accuracy, reproducibility, versatility and ease of use for the particle sizing of APIs (active pharmaceutical ingredients).
Today, Mastersizer is used to analyse wet and dry at various points in the workflow, including preclinical development, clinical development and scale-up, and manufacturing.
Figure 1: The API workflow and the challenges that can be resolved with the help of particle sizing data acquired on the Mastersizer 3000+.
The Mastersizer 3000+ builds on this success and decades of technical knowledge and experience.
How do the new and existing features come together? Read on for an overview of why the Mastersizer remains top of the field for generation of reliable particle size distributions (PSDs) for APIs.
Mastersizer 3000+ embodies groundbreaking easy-to-use capabilities that boost your confidence during your work and in your results. Excellent particle sizing performance is complemented by software that eases your workload. Fuelled by automated data analysis algorithms and compliance supporting software, Mastersizer 3000+ is the smartest way to measure particle size.
Imagine having your own personal laser diffraction expert to guide you through everyday data-quality challenges – someone to spot issues as they emerge, provide independent assessments of what’s wrong, and make suggestions on how to resolve them. Well, you can have all this and more with Data Quality Guidance.
Optimizing your method development is crucial to achieving reliable particle-sizing results – but how many of us can be 100% sure of getting every standard operating procedure (SOP) perfect? By guiding you through every aspect of method development, SOP Architect eliminates the risk of unintentionally deviating from best-practice.
How can you prevent unwanted contaminants from slowing down progress during your measurement? The answer is to use Size Sure, which reliably differentiates between steady-state and transient signals. With Size Sure, you’ll understand your sample better, improve confidence for routine measurements, and get your method development right first time.
Accelerating time to market while ensuring compliance with regulatory requirements is key to succeeding in today’s pharmaceutical industry. From instrument qualification to compliance and auditing software, Malvern Panalytical will help you minimize the risks associated with data integrity in the regulated environment.
It’s time things changed around here… introducing the Mastersizer 3000+
In this studio event, Malvern Panalytical introduced the Mastersizer 3000+: the future of particle size analysis. By combining world-leading sizing performance with game-changing software solutions, this instrument makes getting the best-quality particle size data easier than ever.
The Mastersizer's Product Manager, Paul Senior, was joined by expert guests to explore what’s new for the Mastersizer through roundtable discussions, demos, a Q&A, and more.
Watch to learn how the Mastersizer is now diving even deeper into the core of particle size analysis.
